scholarly journals Quality Management in Polish Biobanking Network—Current Status Before the Implementation of Unified and Harmonized Integrated Quality Management System

2022 ◽  
Vol 8 ◽  
Author(s):  
Agnieszka Matera-Witkiewicz ◽  
Magdalena Krupińska ◽  
Patrycja Sitek ◽  
Michał Laskowski ◽  
Karolina Zagórska ◽  
...  

In 2017, Polish Biobanking Network was established in Poland, within BBMRI.pl project titled “Organization of Polish Biobanking Network within the Biobanking and Biomolecular Resources Research Infrastructure BBMRI-ERIC” as a strategic scientific infrastructure concept. One of the key elements of the project was the verification of the current status of QMS in the Polish biobanking institutions and the implementation of common solutions. The main goal was to indicate the current QMS level and determine the starting points for QMS development for each biobank of the Polish Biobanking Network (PBN). Within 3 years, 35 audit visits were performed. The current status and the level of QMS implementation in each biobank were assessed. Five hundred and seventy recommendations were prepared. The data was analyzed using Fischer Exact test to determine whether or not a significant association was observed. Three areas of analysis were covered: (1) BBMRI.pl status, (2) QMS implementation level and (3) private/public party, respectively. The results were discussed within 15 areas. Concluding remarks showed that some differences were observed in the case of subgroups analysis. There is convergence in QMS within the biobanks where Tissue Banks are located. Moreover, some discrepancies between the QMS implementation level in BBMRI.pl Consortium biobanks and PBN biobanks are observed. Nevertheless, the consortium members are obliged to prepare other biobanks willing to enter the PBN as Members/Observers or which already are in the PBN, so that they can meet the requirements of the quality management system that will enable efficient management of biobanking processes in these units. That is why some actions within BBMRI.pl projects are organized to help the whole biobanking community in Poland implement the harmonized solution.

2015 ◽  
Vol 22 (3) ◽  
pp. 488-504 ◽  
Author(s):  
Rateb J Sweis ◽  
Hala Jamal Al-Ghawi ◽  
Noor Abdel-Aziz AlSaleh ◽  
Zu'bi M.F Al-Zu'bi ◽  
Bader Y Obeidat

Purpose – The purpose of this paper is to gain a better understanding of internal benchmarking through the evaluation of quality management in two quality departments (Quality Assurance (QA) and Quality Control (QC)) in a pharmaceutical company by utilizing total quality index (TQI). Design/methodology/approach – In order to achieve the above-mentioned purpose a structured questionnaire was used to assess the gap between the ideal and current status of the quality management system. The mean differences between the current and ideal states for the eight critical factors were compared for the two departments using t-test. Findings – There is difference in the actual and ideal scores on three out of eight critical factors between the QA and QC departments. Practical implications – The internal benchmarking process which was applied in this case study can be applied in other pharmaceutical companies in order to improve the status of the quality management system and achieve competitive advantage. Originality/value – Benchmarking of total quality management (TQM) can improve the performance of organizations. The benchmarking tool used in this study TQI is an information technology-supported tool that helps managers assess a TQM program by enabling the cost-effective measurement of key organizational processes. TQI measures the ideal and actual quality management along eight critical factors synthesized by Saraph et al. (1989).


2017 ◽  
Vol 17 (1) ◽  
Author(s):  
José Álvarez García ◽  
María de la Cruz Del Río Rama ◽  
Biagio Simonetti

The aim of the research is to analyze the impact of the perceived benefits of implementation and subsequent certification of a Quality Management System on the implementation level of the critical quality factors and results obtained. The empirical study was conducted in 100 of the 227 rural accommodations certified in Spain. The methodology consists of a descriptive analysis of the benefits perceived by the establishments and conducting a factor analysis, in order to determine the structure of the benefits and lastly, the hypotheses are contrasted and verified using a cluster analysis. The results obtained show that the benefits in this sector are grouped into two clusters; internal and external benefits, and it has been confirmed that the higher the benefit levels arising from the implementation and certification, the higher the implementation levels of the critical factors and results obtained.Keywords: Quality Management; Q for Tourist Quality; Benefits; Critical Factors; Results; Tourist Accommodation.


2015 ◽  
Vol 27 (1) ◽  
pp. 150-162 ◽  
Author(s):  
Vasileios Ismyrlis ◽  
Odysseas Moschidis

Purpose – The purpose of this paper is to examine the benefits of ISO 9001 certification and the association between them, the level of implementation of the critical success factors (CSFs) required for the appropriate functioning of the quality management system in ISO 9001:2008 certified companies and between other demographic variables. Design/methodology/approach – A research project was carried out in Greek companies from all business sectors using the questionnaire technique. The selected companies implement a quality management system in accordance with the ISO 9001:2008 standard. Correspondence analysis, a methodology from the field of multidimensional statistics, was used to identify significant differences between the effects on performance and other variables such as the implementation level of CSFs relating to the quality management system and years of certification. Findings – External benefits seem to be more important than internal benefits. The least important benefits were mostly business results, such as profits, costs and market share. Differences were detected between the level of performance and certain demographic variables such as the use of International Organization for Standardisation (ISO) alone, size and years of certification. The certified companies have generally benefited from ISO implementation. Research limitations/implications – The study was based on the perceptions (subjective data) of only one quality manager/representative from each company. The motives for ISO certification, which can seriously affect the benefits derived, were not examined. Practical implications – The measures presented here can be used by certified companies to evaluate performance (financial or not) related to ISO 9001 certification and to discover those factors that contribute to the better exploitation of the ISO 9001:2008 standard. Originality/value – This paper aims to evaluate performance since the implementation of the ISO 9001:2008 standard in Greek companies, which are confronting a tough economic environment and to analyse this data with a methodology from the multidimensional field, with the complementary use of some special tables of coincidence.


2018 ◽  
Vol 3 (01) ◽  
pp. 45
Author(s):  
Nur Hidayat ◽  
Indah Kusuma Hayati

Recently, the evolvement of globalization era has been the global challenges that cannot be avoided either by private or government sectors, and they are requested to be survived encountering such the condition. The implementation of Quality Management System (QMS) in the operational company is the way how to guarantee the quality of products or services offered to the people. One of the purposes of QMS implementation is to provide a prime satisfaction to the customers. The impact of QMS implementation is expected to increase job performance of the employees. Besides the implementation of Quality Management System (QMS), the impact of global challenges has been increasing the competitive efforts to execute more effective production process. However, it has required manpower protection accordingly. This research aims to find out whether the implementation of quality management system and safety and healthy at work management system have impacted on the job performance of employees. Objects of this research are the employees in the production department at PT Guna Senaputra Sejahtera Plant 1 Bogor. Data analysis technique of this research has applied software Smart PLS (Partial Least Square). PLS has estimated a model of correlation among the latent variables and correlation between latent variables and its indicators. Result of data processing has indicated that the implementation of Quality Management System (QMS) and system of safety and healthy at work have positively and significantly impacted job performance of employees.Keywords : Quality Management System (QMS), Safety and Healthy at Work System ( SHWS / SMK3), and Job Performance of Employees


2012 ◽  
pp. 1083-1088
Author(s):  
O.H. Ando Junior ◽  
M.O. Oliveira ◽  
J.M. Neto ◽  
A.D. Spacek ◽  
R.C.B. Leborgne ◽  
...  

2020 ◽  
Vol 14 (3) ◽  
pp. 805-816
Author(s):  
Zdravko Krivokapić ◽  
◽  
Miladin Stefanović

2010 ◽  
Vol 4 (4) ◽  
pp. 1-10
Author(s):  
Hajer Ben Mahmoud ◽  
Raouf Ketata ◽  
Taieb Ben Romdhane ◽  
Samir Ben Ahmed

Author(s):  
Konstantin S. Varaksin ◽  
◽  
Artem S. Makarov ◽  
Alexander Y. Lyapin ◽  
◽  
...  

The updated edition of the ISO/IEC 17025 standard introduced significant changes to the structure, terminology, resource requirements, processes, quality management system of testing and calibration laboratories. New requirements were established for the organization of laboratory activities – a process approach and risk-based thinking, which provides for a reduction in part of the prescriptive requirements and the introduction of requirements based on the analysis of the performance of actions. In accordance with GOST ISO IEC 17025-2019, the laboratory must authorize personnel to perform specific laboratory activities, as well as guarantee their competence. This article discusses the organization of the competence management system for the personnel of the laboratories of the organizations of Transneft system using the laboratory information management system (LIMS). The model of the process implementation has been described. It has been established that the competence test system allows you to regularly monitor the skills and knowledge of laboratory workers both in terms of the elements of the Quality Management System and in the applied measurement (test) methods. The personnel responsibility matrix implemented in LIMS regulates the powers and functionality of employees, ensuring that employees are allowed to perform work in accordance with their competence. The functions implemented in LIMS made it possible to automate the management of the competence of laboratory workers in accordance with the requirements of GOST ISO/IEC 17025-2019 and other regulatory documents.


Sign in / Sign up

Export Citation Format

Share Document